Medical device durability test apparatus having an integrated particle counter and method of use
AssigneeDynatek Laboratories, Inc.
InventorsJames Conti, Elaine Strope
Life of this patent
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Abstract
Apparatuses and methods for determining particle shed rates of implantable or inter-dwelling devices are disclosed. Durability test apparatuses with integrated particle counters produce time-dependent particle shed rate profiles. The apparatuses are designed to accommodate pulsatile flow, resembling a heartbeat at the implantable device. In an embodiment, the pulsatile flow is converted to a steady flow before fluid enters the integrated particle counter.
Claims14
An apparatus for determining a particle shed rate of an implantable medical device comprising:
- a pump that moves fluid in contact with the implantable medical device;
- and
- a particle counter, the particle counter collects data representative of a time-dependent particle shed profile of the implantable medical device,
- wherein the pump, the implantable medical device, and the particle counter are in fluidic communication.
A method of determining a particle shed rate of an implantable medical device comprising:
- deploying the implantable medical device in a durability test apparatus;
- contacting fluid with the implantable medical device;
- and
- analyzing the fluid using an in-line particle counter.
A method of determining a time-dependent particle shed profile of an implantable medical device comprising:
- deploying the implantable medical device in a durability test apparatus;
- continuously cycling fluid through the durability test apparatus,
- wherein the durability test apparatus has an in-line particle counter and an in-line filter;
- and
- analyzing the fluid with the in-line particle counter over a period of time ranging from about 1 hour to 1 year.
Dependencies are inferred from the claim text.